Device especially useful for hernia repair surgeries and methods thereof

ABSTRACT

An elongate open-bored applicator (EOBP) adapted to deploy a mesh comprising (a) at least one inflatable contour-balloon, (b) at least one inflatable dissection balloon. The inflatable contour-balloon and the inflatable dissection balloon are adjustable and located at the distal portion; and, (c) at least one actuating means located at the proximal portion. The actuating means is in communication with the inflatable contour-balloon and the inflatable dissection balloon. The actuating means is adapted to provide the inflatable contour-balloon and the inflatable dissection balloon with independent activation and/or de-activation.

RELATED CASE INFORMATION

This application is a continuation of U.S. patent application Ser. No.13/770,637, which is a continuation of U.S. patent application Ser. No.12/516,373, which is a National Phase Application of PCT Application No.PCT/IL2007/001463 having an International Filing Date of Nov. 27, 2007,which claims the benefit of U.S. Provisional Patent Application No.60/861,095, filed on Nov. 27, 2006.

FIELD OF THE INVENTION

The present invention generally related to a device especially useful inhernia repair and a method of using the same.

BACKGROUND OF THE INVENTION

This invention generally relates to a device, especially useful forhernia repair surgery.

Hernia, denoted hereinafter for umbilical hernia, ventral hernia,postoperative ventral hernia epigastric hernia, spiegelian herniainguinal hernia, etc. is a common medical condition in which an organprotrudes through an opening in its surrounding walls (especially in theabdominal region). Hernia is sometimes treated in a tension free repair,such as implementation of meshes, patches etc. This procedure requiresthe insertion of a wide mesh via a relatively small aperture such thatthe mesh is located in a posterior layer parallel to the abdominal wall.The insertion of the mesh implants to the abdominal wall by means oflaparoscopic technique or similar medical procedures requires more thanone aperture and thus the abdominal wall is punctured several times.Those procedures require anesthesia and usually demand a relatively longhealing time.

One of the major problems of the above procedure is the unrolling orspreading and the positioning or deploying of the mesh inside theabdominal or the pre-peritoneal cavity. The step of unrolling the mesh,directing the right side of the mesh, positioning and fixating the meshand positioning it in the right place usually adds significantly to thetime required for carrying out the procedure. Moreover, inserting themesh/patch into the body without a trocar may expose the mesh/patch toinfections.

Some techniques suggested in the literature disclose mesh-like fortreating hernia. Those techniques fail to guarantee even, complete andsmooth deployment of the mesh, without formation of wrinkles, and cannotensure full anchoring of the implant to the abdominal wall. U.S. Pat.No. 5,824,082 ('082) relates to a prosthetic hernia repair patch thatcan be rolled into a tube for laparoscopic delivery through a trocar andwhich deploys to a generally planar form when ejected from the trocarinto the abdominal cavity. The deployment of the prosthetic is done byembedding a wire frame made of shape memory alloys into the prosthetic.When the prosthetic is inserted into the body it is heated thus,activated—i.e. it springs into its functional, predeterminedconfiguration and deploys the patch. However, embedding a wire frame ina prosthetic is complicated.

Thus, there is still a long felt need for a device that is simple, willshorten the time required for the spreading and the positioning of themesh inside the body and will be inserted via a single small-boreopening.

SUMMARY OF THE INVENTION

It is one object of the invention to disclose inflatable contour-balloonuseful in minimal invasive and/or open surgery; wherein at least aportion of said inflatable contour-balloon is positioned in the contourof a mesh and/or a patch and/or a net; further wherein said inflatablecontour-balloon is adapted to spread and/or deploy said mesh and/or saidpatch and/or said net in the abdominal cavity and/or pre-peritonealand/or space and/or hollow body organs and/or natural and/or artificialorifices and/or spaces and/or post operative spaces.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis especially adapted for use in hernia repair surgery.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonadditionally comprising means adapted to adjust the center of saidinflatable contour-balloon to the center of said hernia.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonadditionally comprising means adapted to ensure the right side of saidmesh or said patch or said net is directed to said abdominal cavityand/or said pre-peritoneal and/or said space and/or said hollow bodyorgans and/or said natural and/or said artificial orifices and/or saidspaces and/or said post operative spaces.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis provided with means enabling coupling of inflating means to saidinflatable contour-balloon.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said means is selected from agroup comprising at least one radial tube, non radial tubes.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflating means isselected from a group consisting manually inflating pump, motorizedinflating pump.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis provided with means enabling threading of said mesh and/or said patchto said inflatable contour-balloon.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said means is selected from agroup comprising at least one slit.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis glued to said mesh and/or said patch and/or said net

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis provided with means enabling sewing of said inflatablecontour-balloon to said mesh and/or patch and/or said net.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-balloonis made of a group comprising biocompatible materials, self-dissolvingmaterials and shape memory materials.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein the shape of said inflatablecontour-balloon is selected from a group comprising a polygonal shape, acurved shape, a symmetrical, a non-symmetrical shape, a linear shape,continues, non-continues, a concave shape, a irregular shape, asquare-like shape, a rectangular shape, an oval shape, a U-like shape, agrid-like shape, a flat structure, a 3D structure and a rake-like shapeor any combination thereof.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein said inflatable contour-ballooncomprises at least two independent parts.

It is another object of the invention to disclose the inflatablecontour-balloon as define above, wherein the configuration is asdescribed in any of FIG. 13 to FIG. 17.

It is another object of the invention to disclose a method for spreadingand/or deploying a mesh and/or a patch, useful in minimal invasiveand/or open surgery. The method comprises step selected inter alia from(a) obtaining an inflatable contour-balloon as define above; (b)attaching said inflatable contour-balloon to said mesh and/or to saidpatch; (c) coupling said inflating means to said inflatablecontour-balloon; (d) adjusting said inflatable contour-balloon; (e)inserting said adjusted inflatable contour-balloon into abdominal cavityand/or pre peritoneal and/or hollow body organs and/or natural and/orartificial orifices and/or spaces and/or post operative spaces; and, (f)inflating at least a portion of said inflatable contour-balloon via saidinflating means; thereby spreading and/or deploying said mesh and/orsaid patch in said abdominal cavity and/or said pre-peritoneal and/orsaid hollow body organs and/or said natural and/or said artificialorifices and/or said spaces and/or said post operative spaces.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of uncoupling said inflatingmeans from said inflatable contour-balloon.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of extracting said inflatablecontour-balloon from said abdominal cavity and/or said pre-peritonealand/or said hollow body organs and/or said natural and/or saidartificial orifices and/or said spaces and/or said post operativespaces.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of deflating said inflatablecontour-balloon.

It is another object of the invention to disclose the method as defineabove, especially in hernia repair surgery.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of fitting the center of saidinflatable contour-balloon to the center of said hernia.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of ensuring the right side ofsaid mesh or said patch or said net is directed to said abdominal cavityand/or said pre-peritoneal and/or said space and/or said hollow bodyorgans and/or said natural and/or said artificial orifices and/or saidspaces and/or said post operative spaces.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of threading said mesh or/andsaid patch or/and said net to said inflatable contour-balloon.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of gluing said mesh or/and saidpatch or/and said net to said inflatable contour-balloon.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of selecting said inflatablecontour-balloon from a group comprising biocompatible materials,self-dissolving materials, shape memory materials.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of selecting the shape of saidinflatable contour-balloon from a group comprising a polygonal shape, acurved shape, a symmetrical, a non-symmetrical shape, a linear shape,continues, non-continues, a concave shape, a irregular shape, asquare-like shape, a rectangular shape, an oval shape, a U-like shape, agrid-like shape, a flat structure, a 3D structure and a rake-like shapeor any combination thereof.

It is another object of the invention to disclose the method as defineabove, additionally comprising the step of continuing inflating saidinflatable contour-balloon according to a predetermined medical need.

It is another object of the invention to disclose an elongate open-boredapplicator (EOBP) useful in minimal invasive surgery; said EOBP having adistal portion that is insertable into the abdominal cavity and/orpre-peritoneal and/or space and/or hollow body organs and/or naturaland/or artificial orifices and/or spaces and/or post operative spaces;and a proximal portion that remains outside said body. The EOBPcomprising:

-   -   a. at least one inflatable contour-balloon as defined above;    -   b. at least one inflatable dissection balloon; said inflatable        contour-balloon and said inflatable dissection balloon are        adjustable and located at said distal portion; and,    -   c. at least one actuating means located at said proximal        portion; said actuating means is in communication with said        inflatable contour-balloon and said inflatable dissection        balloon; said actuating means is adapted to provide said        inflatable contour-balloon and said inflatable dissection        balloon with independent activation and/or de-activation;

wherein said device is adapted to spread and/or deploy a mesh and/or apatch and/or a net in said abdominal cavity and/or in saidpre-peritoneal and/or in said space and/or hollow body organs and/or insaid natural and/or artificial orifices and/or said spaces and/or saidpost operative spaces.

It is another object of the invention to disclose the EOBP as definedabove, wherein said actuating means additionally comprises inflatingmeans used to inflate said at least one inflatable dissection balloonand said at least one inflatable contour-balloon.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP is especially adapted for use in hernia repairsurgery.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP additionally comprising means adapted to adjustthe center of said inflatable contour-balloon to the center of saidhernia.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP additionally comprising means adapted to ensurethe right side of said mesh or said patch or said net is directed tosaid abdominal cavity and/or said pre-peritoneal and/or said spaceand/or said hollow body organs and/or said natural and/or saidartificial orifices and/or said spaces and/or said post operativespaces.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP is provided with means enabling coupling ofinflating means to said inflatable contour-balloon; and the coupling ofinflating means to said inflatable dissection balloon.

It is another object of the invention to disclose the EOBP as definedabove, wherein said means is selected from a group comprising at leastone radial tube, non radial tubes.

It is another object of the invention to disclose the EOBP as definedabove, wherein said inflating means is selected from a group comprisingmanually inflating pump, motorized inflating pump.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP is provided with means enabling threading ofsaid mesh and/or said patch to said inflatable contour-balloon.

It is another object of the invention to disclose the EOBP as definedabove, wherein said means is selected from a group comprising at leastone slit.

It is another object of the invention to disclose the EOBP as definedabove, wherein said inflatable contour-balloon is glued to the edges ofsaid mesh and/or said patch and/or said net.

It is another object of the invention to disclose the EOBP as definedabove, wherein said EOBP is provided with means enabling sewing of saidinflatable contour-balloon to said mesh and/or patch and/or said net.

It is another object of the invention to disclose the EOBP as definedabove, wherein said inflatable contour-balloon and/or said dissectionballoon is made of a group comprising biocompatible materials,self-dissolving materials and shape memory materials.

It is another object of the invention to disclose the EOBP as definedabove, wherein the shape of said inflatable contour-balloon and/or saidinflatable dissection balloon is selected from a group comprising apolygonal shape, a curved shape, a symmetrical, a non-symmetrical shape,a linear shape, continues, non-continues, a concave shape, a irregularshape, a square-like shape, a rectangular shape, an oval shape, a U-likeshape, a grid-like shape, a flat structure, a 3D structure and arake-like shape or any combination thereof.

It is another object of the invention to disclose the EOBP as definedabove, wherein said inflatable contour-balloon comprises at least twoindependent parts.

It is another object of the invention to disclose the EOBP as definedabove, configured as described in any of FIG. 13 to FIG. 17.

It is another object of the invention to disclose the EOBP as definedabove, configured as described in any of FIG. 10a to FIG. 10 g.

It is another object of the invention to disclose a method for spreadingand/or deploying a mesh and/or a patch, useful in minimal invasiveand/or open surgery. The step comprises step selected inter alia from(a) obtaining an EOBP as defined above; (b) attaching said inflatablecontour-balloon to said mesh and/or to said patch; (c) coupling saidinflating means to said inflatable contour-balloon and said inflatabledissection balloon; (d) adjusting said inflatable contour-balloon andsaid inflatable dissection balloon; (e) introducing said device intoabdominal cavity and/or pre-peritoneal and/or hollow body organs and/ornatural and/or artificial orifices and/or spaces and/or post operativespaces; and, (f) inflating at least a portion of said inflatablecontour-balloon via said inflating means; thereby spreading and/ordeploying said mesh and/or said patch in said abdominal cavity and/orsaid pre-peritoneal and/or said hollow body organs and/or said naturaland/or said artificial orifices and/or said spaces and/or said postoperative spaces.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of inflating at least a portionof said inflatable dissection balloon via said inflating means.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of uncoupling said inflatingmeans from said inflatable contour-balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of uncoupling said inflatingmeans from said inflatable dissection balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of deflating said inflatablecontour-balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of deflating said inflatabledissection balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of extracting said inflatablecontour-balloon from said abdominal cavity and/or said pre-peritonealand/or said hollow body organs and/or said natural and/or saidartificial orifices and/or said spaces and/or said post operativespaces.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of extracting said inflatabledissection balloon from said abdominal cavity and/or said pre-peritonealand/or said hollow body organs and/or said natural and/or saidartificial orifices and/or said spaces and/or said post operativespaces.

It is another object of the invention o disclose the method as definedabove, especially in hernia repair surgery.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of fitting the center of saidinflatable contour-balloon to the center of said hernia.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of ensuring the right side ofsaid mesh or said patch or said net is directed to said abdominal cavityand/or said pre-peritoneal and/or said space and/or said hollow bodyorgans and/or said natural and/or said artificial orifices and/or saidspaces and/or said post operative spaces.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of threading said mesh or/andsaid patch or/and said net to said inflatable contour-balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of gluing said mesh or/and saidpatch or/and said net to said inflatable contour-balloon.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of selecting said inflatablecontour-balloon and/or said inflatable dissection balloon from a groupcomprising biocompatible materials, self-dissolving materials, shapememory materials.

It is another object of the invention to disclose the method as definedabove, additionally comprising the step of selecting the shape of saidinflatable contour-balloon and/or said inflatable dissection balloonfrom a group comprising a polygonal shape, a curved shape, asymmetrical, a non-symmetrical shape, a linear shape, continues,non-continues, a concave shape, a irregular shape, a square-like shape,a rectangular shape, an oval shape, a U-like shape, a grid-like shape, aflat structure, a 3D structure and a rake-like shape or any combinationthereof.

It is another object of the invention to disclose the EOBP as definedabove, wherein said actuating means are adapted to extract saidinflatable contour-balloon and/or said inflatable dissection balloonfrom said abdominal cavity and/or in said pre-peritoneal and/or in saidspace and/or hollow body organs and/or in said natural and/or artificialorifices and/or said spaces and/or said post operative spaces.

It is another object of the invention to disclose the EOBP as definedabove, additionally comprising means adapted to anchor said EOBP in saidabdominal cavity and/or in said pre-peritoneal and/or in said spaceand/or hollow body organs and/or in said natural and/or artificialorifices and/or said spaces and/or said post operative spaces.

It is still an object of the invention to disclose the method as definedabove, additionally comprising the step of continuing inflating saidinflatable dissection balloon according to a predetermined medical need.

It is lastly an object of the invention to disclose the method asdefined above, additionally comprising the step of continuing inflatingsaid inflatable contour-balloon according to a predetermined medicalneed.

BRIEF DESCRIPTION OF THE FIGURES

In order to understand the invention and to see how it may beimplemented in practice, a plurality of preferred embodiments will nowbe described, by way of non-limiting example only, with reference to theaccompanying drawings, in which

FIG. 1 schematically present general view of the of the elongateopen-bored applicator.

FIGS. 1a-1d schematically display wings-like means adapted to anchor theelongate open-bored applicator 100 within the tissue and to thrust thetissue.

FIG. 2 schematically display the elongate open-bored applicator once theposterior portion is inside the body.

FIGS. 2a-2d schematically present general view of the applicator, theinflatable dissection balloon, the inflatable contour-balloon and themesh.

FIG. 3 schematically presents cut view of the in the middle of theapplicator. FIG. 4a and FIG. 4b displaying an applicator according toanother embodiment of the present invention.

FIG. 5 schematically presents the applicator according to anotherembodiment of the present invention.

FIG. 6a presents a cut view in the middle of the applicator 100according to the embodiment described in FIG. 5.

FIG. 6b displays the applicator according to another embodiment of thepresent invention.

FIGS. 7a to 7e schematically present the mesh implanting processaccording to one embodiment of the present invention.

FIGS. 8a to 8e schematically present the mesh implanting processaccording to another embodiment of the present invention.

FIGS. 9a to 9g present possible solutions or means for centering themesh with respect to the inflatable dissection balloon.

FIGS. 10a-10g present possible designs of the inflatable dissectionballoon and possible coupling options between said inflatable balloonand the mesh.

FIGS. 11a-11d present possible valve designs for sealing the airway ofthe inflatable contour-balloon.

FIG. 12 presents a possible design a handle which is also used as an airpump.

FIGS. 13a-13o schematically display a different design of the inflatablecontour-balloon; furthermore FIGS. 13a-13o display different options forconnecting the mesh/net/patch to the balloons.

FIGS. 14, 15 and 16 schematically display different rectangle shapes ofthe inflatable contour-balloon and the mesh.

FIG. 17 schematically represents the inflatable contour-balloon and themesh according to another embodiment of the present invention.

FIG. 18 displays an option of attaching the mesh to the inflatablecontour-balloon.

FIG. 19 displays the inflatable contour-balloon with the mesh threadedinside the slits.

FIGS. 20a and 20b display a more detail look of the same.

FIGS. 20c-20e display a different way to couple the inflatablecontour-balloon and the mesh.

FIG. 20f displays another design of the inflatable contour-balloon andthe mesh.

FIGS. 20g and 20h display another option to couple the inflatablecontour-balloon and the mesh.

FIGS. 20i-20j display different designs of the inflatablecontour-balloon.

DETAIL DESCRIPTION OF THE INVENTION

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of said invention and sets forth the best modes contemplated by theinventor of the carrying out this invention. Various modifications,however, is adapted to remain apparent to those skilled in the art,since the generic principles of the present invention have been definedspecifically to provide an inflatable contour-balloon useful in minimalinvasive and/or open surgery. The inflatable contour-balloon positionedin the contour of a mesh and/or a patch and/or a net. The inflatablecontour-balloon is adapted to spread and/or deploy a mesh and/or a patchand/or a net in the abdominal cavity and/or pre-peritoneal and/or spaceand/or hollow body organs and/or natural and/or artificial orificesand/or spaces and/or post operative spaces.

The present invention also provides a method for spreading and/ordeploying a mesh and/or a patch, useful in minimal invasive and/or opensurgery. The method comprises step selected inter alia from (a)obtaining an inflatable contour-balloon; (b) attaching the inflatablecontour-balloon to the mesh and/or to the patch; (c) coupling theinflating means to the inflatable contour-balloon; (d) adjusting theinflatable contour-balloon; (e) inserting the adjusted inflatablecontour-balloon into abdominal cavity and/or pre-peritoneal and/orhollow body organs and/or natural and/or artificial orifices and/orspaces and/or post operative spaces; and (f) inflating at least aportion of the inflatable contour-balloon via the inflating pump;thereby spreading and/or deploying said mesh and/or the patch in theabdominal cavity and/or the pre-peritoneal and/or the hollow body organsand/or the natural and/or the artificial orifices and/or the spacesand/or the post operative spaces.

The present invention also provides a device adapted to spread and/ordeploy a mesh and/or a patch, useful in minimal invasive and/or opensurgery. The device comprising: (a) at least one inflatablecontour-balloon; (b) one inflatable dissection balloon; (c) at least oneactuating means. The device is adapted to spread and/or deploy a meshand/or a. patch and/or a net in the abdominal cavity and/orpre-peritoneal and/or space and/or hollow body organs and/or naturaland/or artificial orifices and/or spaces and/or post operative spaces.

The present invention also provides a method for spreading and/ordeploying a mesh and/or a patch, useful in minimal invasive and/or opensurgery. The method comprises step selected inter alia from (a)obtaining a device; (b) attaching the inflatable contour-balloon to themesh and/or to the patch; (c) coupling the inflating means to theinflatable contour-balloon and the inflatable dissection balloon; (d)adjusting the inflatable contour-balloon and the inflatable dissectionballoon; (e) introducing the device into abdominal cavity and/orpre-peritoneal and/or hollow body organs and/or natural and/orartificial orifices and/or spaces and/or post operative spaces; (f)inflating at least a portion of the inflatable dissection balloon viathe inflating means; and, (g) at least a portion of inflating theinflatable contour-balloon via the inflating means; thereby spreadingand/or deploying the mesh and/or the patch in the abdominal cavityand/or the pre-peritoneal and/or the hollow body organs and/or thenatural and/or the artificial orifices and/or the spaces and/or the postoperative spaces.

The methods can comprise steps selected inter alia from extracting theinflatable contour-balloon and/or the inflatable dissection balloon fromthe abdominal cavity and/or the pre-peritoneal and/or the hollow bodyorgans and/or the natural and/or the artificial orifices and/or thespaces and/or the post operative spaces; continuing inflating theinflatable contour-balloon and/or the inflatable dissection balloonaccording to a predetermined medical need; deflating the inflatablecontour-balloon and/or the inflatable dissection balloon.

The term “balloon” refers hereinafter to any flexible bag which caninflates or expands. The balloon can be made from materials such asrubber, latex, silicone, polyurethane, chloroprene or a nylon fabric orany thermoelastomeric materials. The balloon can be made ofbiocompatible materials, self-dissolving materials or shape memorymaterials.

The term “Hernia” refers hereinafter for umbilical hernia, hiatalhernia, ventral hernia, postoperative hernia, epigastric hernia,spiegelian hernia, inguinal hernia and femoral hernia, generally anyabdominal wall related hernia.

The term “minimally invasive surgery” refers hereinafter to a procedurethat is carried out by entering the body through the skin or through abody cavity or anatomical opening, but with the smallest damagepossible.

The term “Biocompatible materials” refers hereinafter to materials thathave the ability to perform with an appropriate host response in aspecific application. Biocompatible materials have the quality of nothaving toxic or injurious effects on biological systems.

The term “self-dissolving materials” refers hereinafter to materialsthat are degraded by the body's enzymatic and/or hydrolytic pathwaysthrough a reaction against “foreign” material. Some urologists mayprefer self-dissolving materials in catheter simply because then theydon't have to go necessarily through the procedure of removing themafterwards. Examples of self-dissolving polymers are Polydioxanone(PDO), Polycaprolactone (PCL), Polylactic acid (PLA), Polyglycolic acid(PGA), Adipic acid, PEG and glutamic acid.

The term “shape memory materials” refers hereinafter to materials whichcan “remember” there original geometry. After a sample of shape memorymaterials has been deformed from its original geometry, it regains itsoriginal geometry by itself during heating (one-way effect) or, athigher ambient temperatures, simply during unloading (pseudo-elasticityor superelasticity). The thermally induced shape-memory effect has beendescribed for different material classes: polymers, such aspolyurethanes, poly(styrene-block-butadiene), Polydioxanone andpolynorbornene, metallic alloys, such as copper-zinc-aluminium-nickel,copper-aluminium-nickel, and nickel-titanium (NiTi) alloys.

The term “adjusting” or “adjustable” refers hereinafter to rolling,bending, twisting, folding and winding.

The term “activation” refers hereinafter to the act of inflating aballoon.

The term “de-activation” refers hereinafter to the act of deflating theballoon extracting the air out of the balloon).

The term “contour” refers hereinafter to any section (and not only tothe outer edge) of the mesh and/or patch and/or net.

Reference is now FIGS. 1-2 d, which schematically present a general viewof the elongate open-bored applicator 100 according to the presentinvention. The elongate open-bored applicator 100 has an anteriorportion 11 terminated outside the body and a posterior portion 12terminated with an orifice 13 insertable into the abdominal cavityabdominal cavity and/or pre-peritoneal and/or space and/or hollow bodyorgans and/or natural and/or artificial orifices and/or spaces and/orpost operative spaces. The elongate open-bored applicator 100 comprisesat least one inflatable contour-balloon 30, which is attached to thecontours of mesh 20 (the different ways of attaching the inflatablecontour-balloon 30 to mesh 20 will be discussed later on in the detaildescription). The elongate open-bored applicator 100 may additionallycomprises a second inflatable balloon (refers herein after as inflatabledissection balloon) 10. The mesh and the inflatable contour-balloon areadjusted to fit inside the applicator 100. Mesh 20 is adapted to deploywhen injected outside the applicator inside the body cavity. Theelongate open-bored applicator 100 additionally comprises actuatingmeans 14 adapted to push mesh 20 throughout the applicator via saidposterior orifice 13. The actuating means 14 can comprises amaneuverable pistol and/or handles operating the same (denotes as 14 inFIG. 1) or inflating pumps for inflating the inflatable dissectionballoon 10 and the inflatable contour-balloon 30 (denotes as 14 in FIG.2).

Reference is now made to FIGS. 1a-1b , which schematically displaywings-like means 77 adapted to anchor the elongate open-bored applicator100 within the tissue and to thrust the tissue. The wings-like means 77are positioned in the posterior portion 12. FIG. 1a represent thewings-like means 77 in a semi open configuration and FIG. 1b representsthe wings-like means 77 in a fully open configuration. Activation means78 are also provided for activating (i.e. opening and closing) thewings-like means 77. The activation or de-activation of the wings-likemeans 77 by the activation means 78 can be performed by sliding theactivation means 78 towards and away from the posterior portion 12.

The wings-like means 77 can have the configuration as shown in FIGS.1c-1d . In those figures the wings-like means 77 are fixed in theirpositions.

Reference is now made to FIG. 2 which schematically display the elongateopen-bored applicator 100 once the posterior portion 12 is inside thebody. As can be seen from FIG. 2, both the inflatable dissection balloon10 and the inflatable contour-balloon 30 are inflated so as mesh 20 isin parallel to the wall of the abdominal cavity.

The modus in which both the balloon are inflated can include differenttiming. For example, the inflatable contour-balloon 30 is inflated toabout 50% of its volume, then the inflatable dissection balloon 10 isinflated to about 70% of its volume, and then the inflation of theinflatable contour-balloon 30 is completed.

The actuating means 14 are represented in FIG. 2 as two pumps 14 usedfor inflating balloons 10 and 30. It should be pointed out that thepresent invention is not limited to the use of two pumps. One pump canbe used to inflate both balloons 10 and 20 (as seen in FIG. 2a ).

Reference is now made to FIGS. 2a and 2b schematically present generalview of the applicator, the inflatable contour-balloon 30 and mesh 20.According to FIG. 2a the applicator 100 comprises only the inflatablecontour-balloon 30. FIG. 2b is an enclose view of the inflatablecontour-balloon 30 and mesh 20.

Reference is now made to FIGS. 2c and 2d schematically present general.view of the applicator, the inflatable dissection balloon 10, theinflatable contour-balloon 30 and mesh 20. As can be seen in FIG. 2c ,the applicator 100 comprises the inflatable contour-balloon 30 andinflatable dissection balloon 10. FIG. 2d is an enclose view of theinflatable contour-balloon 30, the inflatable dissection balloon 10 andmesh 20.

Those figures (FIGS. 2a-2d ) also display the actuating means 14 (whichare handles is in those figures) enabling the surgeon to control and topump air into the inflatable contour-balloon 30 and to the inflatabledissection balloon 10.

The elongate open-bored applicator is activated as follows: applicator100 is introduced into the wall of the abdominal cavity. Next, at leasta portion of the inflatable dissection balloon 10 is inflated, hencethrusting, Then the inflatable contour-balloon 30 which is attached tomesh 20 is inflated to a predetermined size, such that said mesh islaying in parallel to said wall. Next, the inflatable dissection balloon10 is deflated and evacuated throughout said applicator 100. Finally,applicator 100 is removed and mesh 20 is fastened to the posteriorabdominal wall.

Contour-balloon 30 and/or the inflatable dissection balloon 10 can bemade of a group comprising biocompatible materials, self-dissolvingmaterials such that after a period of time only mesh 20 stays connectedto the tissue. Inflatable contour-balloon 30 can be made of shape memorymaterials.

Inflatable contour-balloon 30 may be covered with mesh 20 all-around.Furthermore, inflatable contour-balloon 30 can be removed out of thebody when mesh 20 is fully spread.

The shape of the inflatable contour-balloon 30 and/or the inflatabledissection balloon 10 can be a polygonal shape, a curved shape, asymmetrical, a non-symmetrical shape, a linear shape, continues,non-continues, a concave shape, a irregular shape, a square-like shape,a U-like shape, a grid-like shape and a rake-like shape or anycombination thereof.

Mesh 20 is attached to the inflatable contour-balloon 30 by means ofgluing, sewing, or threading the mesh into the inflatablecontour-balloon 30. Another option to couple the mesh to the balloon isby velcro. The mesh can be attached to the. inflatable contour-balloon30 by means of gluing the balloon to the mesh such that the balloonremains in the body. Another option is to glue the mesh to theinflatable contour-balloon 30 such that the balloon can be separatedfrom the mesh and extracted from the body. I.e., only the mesh remainsin the body. The actuating means 14 can be used for extracting theinflatable contour-balloon 30 and/or the inflatable dissection balloon10.

Another option is to use the mesh as bedding for building the inflatablecontour-balloon 30. A proofing material is spread on the mesh's fibers.The inflatable contour-balloon 30 will be created by folding the edgesof mesh.

Both the balloons (30 or 10) can be inflated by air, CO2, saline etc.

Reference is now made to FIG. 3, which schematically presents cut viewof the middle of the applicator 100 showing mesh 20, inflatablecontour-balloon 30, inflatable dissection balloon 10 and the relationbetween them.

Reference is now made to FIGS. 4a and FIG. 4b displaying an applicatoraccording to another embodiment of the present invention. According tothis embodiment, the applicator additionally comprising a cover 52 andmeans 51 enabling the surgeon to pull aside the cover 52 from theballoons system.

Reference is now made to FIG. 5, displays the applicator according toanother embodiment of the present invention. According to thisembodiment, the inflatable contour-balloon 30 is positioned above theinflatable dissection balloon 10.

FIG. 6a schematically presents a cut view in the middle of theapplicator 100 according to the embodiment described in FIG. 5.

FIG. 6b displays the applicator according to another embodiment of thepresent invention. According to this embodiment, the inflatablecontour-balloon 30 comprises two independent parts (as seen clearly fromFIG. 20i or 20 j which display a balloon comprising several independentparts). Furthermore, the applicator according to this embodimentcomprises three handles: one for the inflatable dissection balloon 10and two for the inflatable contour-balloon (one for each part).

Reference is now made to FIGS. 7a to 7e , which schematically presentthe mesh implanting process according to one embodiment of the presentinvention. According to this embodiment, the mesh is spread by using theinflatable contour-balloon 30 only (without the inflatable dissectionballoon 10).

According to this embodiment, the applicator 100 comprises mesh 20 andthe inflatable contour-balloon 30.

FIG. 7a schematically shows the surgeon check the hernia area throughthe incision made by the surgeon.

FIG. 7b schematically displays the placement of applicator 100 in theincision made by the surgeon.

In FIG. 7c the inflatable contour-balloon 30 is inflated (thus producinga cavity in which the mesh will be placed) and mesh 20 is spread in itsanterior part.

FIG. 7d shows the surgeon insuring, through the incision, that mesh 20is fully spread.

FIG. 7e shows the incision closed with stitches.

Reference is now made to FIGS. 8a to 8e , which schematically presentthe mesh implanting process according to another embodiment of thepresent invention:

According to this embodiment, the applicator 100 comprises mesh 20, theinflatable contour-balloon 30 and the inflatable dissection balloon 10.

FIG. 8a represents the first step in which the applicator 100 is placedin the incision made by the surgeon.

FIG. 8b represents the second step in which the inflatable dissectionballoon 10 is semi inflated starting to produce a cavity in which mesh20 will be spread in.

FIG. 8c represents the next step in which the inflatable dissectionballoon 10 is inflated and the inflatable contour-balloon 30 is inflatedthus mesh 20 is spread in its anterior part.

FIG. 8d represents the next step in which the inflatable dissectionballoon 10 is emptied and drawn out from the incision while mesh 20stays spread around the incision and lying in parallel to abdominalwall.

FIG. 8e represents the last step in which the incision is closed withstitches.

Reference is now made to FIGS. 9a, 9b and 9c presenting a possiblesolutions or means for centering mesh 20 with respect to the inflatabledissection balloon 10.

In FIG. 9a , centralization of mesh 20 may be realized with wires 91stretching from the posterior side of the inflatable dissection balloon10 to mesh 20.

Centralization of mesh 20 is realized by using Velcro and/or doublesided masking tape and/or small Silicon tubes 92 that hold the meshuntil the inflatable dissection balloon 10 is inflated enough to tearthe connection. FIG. 9b displays the inflatable dissection balloon 10with Velcro and/or double sided masking tape and/or small Silicon tubes92. FIG. 9c displays the inflatable dissection balloon 10 with Velcroand/or double sided masking tape and/or small Silicon tubes 92,attached/combined/adjusted with the inflatable contour-balloon 30 andmesh 20. FIG. 9d displays the Velcro and/or double sided masking tapeand/or small Silicon tubes 92 after the inflatable dissection balloon 10is inflated enough such that the connection between the inflatabledissection balloon 10 and mesh 20 is torn apart.

In FIGS. 9e-9f centralization of mesh 20 is made by a ribbon 90 thatsurrounds the balloon and holds the mesh tight to the dissectionballoon. When the inflatable dissection balloon 10 is inflated, theribbon expands until mesh 20 is relapsed. FIG. 9e displays theinflatable dissection balloon 10 is inflated such that mesh 20 isrelapsed. FIG. 9f displays the inflatable dissection balloon 10 prior tothe inflation.

In FIG. 9g , rigid but flexible stripes 91 are leaning on the inflatablecontour-balloon 30. just like the mechanism of an umbrella, when thestripes 91 are pushed they stretch mesh 20. The inflatable dissectionballoon 10 makes room in between the tissues and strengths the centralpart of the mesh 20.

Reference is now made to FIGS. 10a-10g presenting possible designs ofthe inflatable dissection balloon 10 and possible coupling optionsbetween said inflatable balloon 10 and the mesh 20. As can be seen fromthe figures tube 101 is used to inflate the inflatable dissectionballoon 10 and tube 102 is used to inflate the inflatablecontour-balloon 30.

As can be seen from FIGS. 10a and 10b the inflatable dissection balloon10 surrounds mesh 20 and the inflatable contour-balloon 30.

In FIGS. 10a-10b mesh 20 and the inflatable contour-balloon 30 arepositioned in the internal portion of the inflatable dissection balloon10. FIG. 10a is a cut view of the same.

In FIG. 10c mesh 20 and the inflatable contour-balloon 30 are positionedin the internal portion of the inflatable dissection balloon 10. FIG.10d is a cut view of the same. The difference between FIGS. 10a and 10cis the location of the two balloon with respect to each other. In FIGS.10a and 10b the inflatable dissection balloon 10 surrounds mesh 20 andthe inflatable contour-balloon 30 from bellow and in FIGS. 10c and 10dthe inflatable dissection balloon 10 surrounds mesh 20 and theinflatable contour-balloon 30 from above.

In FIG. 10e mesh 20 and the inflatable contour-balloon 30 are positionedin the inner portion 103 of the inflatable dissection balloon 10.

In FIG. 10f mesh 20 and the inflatable contour-balloon 30 areincorporated within inflatable dissection balloon 10. FIG. 10g is a cutview of the same.

Reference is now made to FIGS. 11a-11d presenting possible valve designsfor sealing the airway of the inflatable contour-balloon 30.

FIG. 11a displays a possible valve design according to one embodiment ofthe present invention. According to this embodiment, a rigid tube 110 ininserted into the flexible inflating tube 102. The inside portion of thetube 102 is covered with glue 111. When the rigid tube 110 is drawn outof the flexible inflating tube 102, the inside portion of said tube 102stick together and do not allow air to escape.

FIG. 11b displays another possible design of a valve. In thisembodiment, the valve is made of a rigid tube 113. The rigid tube 113 ispositioned inside the flexible inflating tube 102. In the inside of theflexible inflating tube 102 there are leafs 114 covered with glue. Whenthe rigid tube 113 is drawn out of the flexible inflating tube 102,leafs 114 inside the inflating tube 102 expand and stick to each otherand thus do not allow air to escape.

FIGS. 11c and 11d display a rubber band 115 positioned around the rigidtube 116. When the rigid tube 116 is drawn out of the flexible inflatingtube 102 (see FIG. 11d ), the rubber band 116 applies force on theflexible inflating tube 102 and thus do not allow air to escape.

Reference is now made to FIG. 12, which presents a possible design ahandle which is also used as an air pump. The air pump can be usedeither to pump air or to empty the air out of the inflatablecontour-balloon 30.

Reference is now made to FIG. 13, which schematically displays differentdesigns of the inflatable contour-balloon 30.

The inflatable contour-balloon 30 may have a flat structure as displaysin FIGS. 13a, 13b, 13c , or a 3D structure as displays in FIGS. 13d, 13eand 13 f.

The inflatable contour-balloon 30 may not have a complete closed shapeas can be seen in FIGS. 13g and 13h . The different parts of theinflatable balloon may be connected to each other with glue, wire,scotch Etc.

The inflating tube 102 may be flexible (FIG. 13i ), or rigid (FIG. 13j). Moreover, the inflating tube 102 may not be connected to the centerof the balloon 30. FIG. 13k represents a different design for theinflatable contour-balloon 30. According to this design, inflatablecontour-balloon 30 has two parts. An internal part 31 and an externalpart 32. Mesh 20 is positioned in between the internal part 31 and theexternal part 32. An inflating tube 102 is coupled to a tube 34, whichpasses through both the internal part 31 and the external part 32. FIG.13l is a cross section area of the same.

In another embodiment of the invention the 2 balloons may be inflatedwith different pumps allowing the use of sequenced pumping.

FIG. 13m represent another different design for the inflatablecontour-balloon 30. According to this design, the inflatablecontour-balloon 30 encapsulate an internal balloon 40 shaped as ano-ring. Mesh 20 is captured in between the inflatable contour-balloon 30and the internal balloon 40. FIG. 13n is a cut and an enlarge view ofthe same. FIG. 13o displays the inflatable contour-balloon 30 and theinternal balloon 40 according to this design.

Reference is now made to FIGS. 14, 15 and 16, which schematicallydisplay different rectangle shapes of the inflatable contour-balloon 30and mesh 20.

As can be seen from FIG. 14, the shape of the inflatable contour-balloon30 is a rectangle shape having two oppositely faced curves. The twocurves can be fused one to the other in a common section. Additionally,according to this embodiment mesh 20 is threaded in slits 7 which arepositioned in two oppositely sides ribs on the rectangle. Inflating tube102 is connected to inflatable contour-balloon 30. An inflating pump 14is connected to the inflating tube 102.

Reference is now made to FIG. 15, which schematically represents theinflatable contour-balloon 30 and the mesh 20 according to anotherembodiment of the present invention. According to this embodiment mesh20 extends beyond the inflatable contour-balloon 30.

Reference is now made to FIG. 16, which schematically represents theinflatable contour-balloon 30 and the mesh 20 according to anotherembodiment of the present invention.

Reference is now made to FIG. 17, which schematically represents theinflatable contour-balloon 30 and mesh 20 according to anotherembodiment of the present invention. According to this embodiment, theinflatable contour-balloon 30 additionally comprises two arcs 10 thatmay replace the function of the dissection balloon. The inflatablecontour-balloon 30 is fixed to its position by creating pressure on themesh/patch towards the abdominal wall.

Reference is now made to FIG. 18, which displays an option of attachingmesh 20 to the inflatable contour-balloon 30. According to thatembodiment, the inflatable contour-balloon 30 additionally comprises atleast one slit 7 into which the edges of mesh 20 are threaded. FIG. 19displays the inflatable contour-balloon 30 with mesh 20 threaded insidethe slits. FIG. 20a and FIG. 20b display a more detail look of the same.

Another way of coupling between the inflatable contour-balloon 30 andthe mesh is by making specials cuts in the mesh such that those cutesurround the balloon as can be seen from FIGS. 20c and 20 d.

Another way to attach the inflatable contour-balloon 30 to the mesh isby double-sided adhesive material as displayed iii FIG. 20e . FIG. 20fdisplays another design of the inflatable contour-balloon 30 and mesh20.

Another option to couple the inflatable contour-balloon 30 and mesh 20is by using special extensions 11 as can be seen in FIGS. 20g and 20h .The special extensions 11 are insertable into extension 18 in the mesh20. The inflatable contour-balloon 30 can additionally comprise means 25(such as bulge, lines, signs and symbols) adapted to adjust the centerof said inflatable balloon to the center of the hernia.

Reference is now made to FIG. 20i , which schematically displays theinflatable contour-balloon 30, which comprises several independent parts40 and several inflating tubes 102 (which will be couple to theinflating means). As can be seen from FIG. 20i tubes 102 are notpositioned in the center of the balloon.

Reference is now made to FIG. 20j , which schematically displays theinflatable contour-balloon 30 comprising several independent parts 40and several inflating tubes. As can be seen from FIG. 20i tubes 102 arenot radial. I.e., tubes 102 are positioned in the perimeter of theinflatable balloon.

1-63. (canceled)
 64. A hernia repair device, comprising: a meshdeployment device comprising an inflatable balloon having an outerperipheral segment, first and second downwardly extending segmentsinward of the outer peripheral segment, and a transverse segmentextending between the first and second downwardly extending segments,wherein the first downwardly extending segment and the outer peripheralsegment form a first enclosed space, the second downwardly extendingsegment and the outer peripheral segment form a second enclosed space,the transverse segment and the outer peripheral segment and the firstand second downwardly extending segments form a third enclosed space anda fourth enclosed space, wherein the third enclosed space is on one sideof the transverse segment and the fourth enclosed space is on anotherside of the transverse segment.
 65. The hernia repair device accordingto claim 64, wherein the mesh deployment device further comprises aninflation tube.
 66. The hernia repair device according to claim 64,further comprising a mesh coupled to the mesh deployment device.
 67. Thehernia repair device according to claim 66, wherein the mesh deploymentdevice further comprises an inflation tube, and the inflation tubepasses through the mesh.
 68. The hernia repair device according to claim66, wherein the mesh comprises a hernia repair mesh.
 69. The herniarepair device according to claim 64, wherein the balloon has a generallyflat structure.
 70. The hernia repair device according to claim 64,wherein said balloon is made of a shape memory material.
 71. The herniarepair device according to claim 64, wherein said balloon has asubstantially non-symmetrical shape.
 72. The hernia repair deviceaccording to claim 66, wherein the balloon is detachable from the meshwithout damaging the balloon or the mesh.
 73. The hernia repair deviceaccording to claim 64, wherein the inside of said balloon comprisesinflation fluid only.
 74. The hernia repair device according to claim66, wherein an area of the balloon is less than 50% of an area of themesh.
 75. The hernia repair device according to claim 66, wherein alargest dimension of the balloon is no larger than a largest dimensionof the mesh.
 76. The hernia repair device according to claim 66, whereinthe inflatable balloon has a top surface and a bottom surface situatedon only one side of the mesh and one the same side of the mesh.
 77. Thehernia repair device according to claim 65, wherein the balloon wheninflated has a smaller length in one direction than the respectivelengths in two directions perpendicular to the one direction wherein thetube is attached to the balloon at a central region of a surface formedin the directions of the two larger lengths.